[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Paracetamol (regular= sustained release - SR)
paracetamol (immediate release - SR)
Included criteria: OA ofthe knee, and experienced mild to moderate pain suitablefor treatment with a simple analgesic. This diagnosis wasconfirmed by X-ray (antero-posterior view of the knee)prior to entry into the study. Patients were required toexperience pain from OA of the knee on at least half ofthe days in the 3 months prior to the screening visit atthe start of the study. The pain was to be exacerbated bymovement or weight-bearing
Excluded criteria: received intra-articular corticosteroids within14 days prior to screening, or if systemic steroids, NSAIDsor other analgesics were required for any medicalcondition.
Pretreatment: Demographic characteristics were comparablebetween groups in the intention to treat population(Table 1) as was also the case for the per protocolpopulation (results not shown)
Intervention Characteristics
Paracetamol (regular= sustained release - SR)
paracetamol (immediate release - SR)
Serious Adverse event
Sponsorship source: We thank all the investigators* and also Carolyn Adnitt and AnneDarby-Dowman from GlaxoSmithKline for their contribution tothis study.
Country: UK
Setting: Primary care
Comments:
Authors name: T. H. Bacon,1 J. G. Hole,2 M. North1 & I. Burnett1
Institution: GlaxoSmithKline, St George’s Avenue, Weybridge, Surrey KT13 0DE, UK, 2Adcroft Surgery, Prospect Place, Trowbridge, Wiltshire BA14 8QA, UK, and also on behalf of Profiad Ltd, Reading, Berkshire RG1 1NY, UK
Email: teresa.h.bacon@gsk.com
Address: GlaxoSmithKline, St George’s Avenue,Weybridge, Surrey KT13 0DE, UK
Study design:
Study grouping:
Open Label:
Cluster RCT:
Baseline Characteristics
Paracetamol 4000 mg/day
Ibuprofen 1200 mg/day
Ibuprofen 2400 mg/day
Included criteria:
Excluded criteria:
Pretreatment:
Intervention Characteristics
Paracetamol 4000 mg/day
Ibuprofen 1200 mg/day
Ibuprofen 2400 mg/day
Frafald, bivirkninger
Sponsorship source: Supported by grant from the National Institute of arthritis and musculoskeletal and skin disorders
Country: USA
Setting: general practice, rheumatology and orthopedic surgery dept. at Indiana School of medicine and surrounding community
Comments:
Authors name: Bradley, Brandt, Katz et al.
Institution: Rheumatology department, Indiana School of medicine, Indiana, USA
Email: not reported
Address:
Study design: Randomized controlled trial
Study grouping: Crossover
Open Label:
Cluster RCT:
Baseline Characteristics
All exposed to Acetaminophen
All exposed to Diclophenac+misoprostol
Included criteria: Patients with osteoarthritis ofthe hip or knee.The major inclusion criteria were age .40 years,Kellgren/Lawrence radiographic grade 2–4 osteoarthritis ofthe hip or knee (16), and a visual analog pain scale (17–19)score of $30 mm (range 0–100 mm).
Excluded criteria: Exclusion criteria wererestricted to severe comorbidities and hypersensitivity to acetaminophen,diclofenac, or misoprostol.
Pretreatment: II. Patientswho were randomized to group I or group II weresimilar in demographic measures of age, sex, maritalstatus, and formal education level; in osteoarthritismeasures of radiographic grade, severity of joint spacenarrowing and osteophytes, and mean global severity ofosteoarthritis at the time of screening; and (other thanfor SF-36 bodily pain, which is likely explained bymultiple comparisons) in measures to assess clinicalstatus from the WOMAC, MDHAQ, and SF-36 questionnairesat screening (
Intervention Characteristics
All exposed to Acetaminophen
All exposed to Diclophenac+misoprostol
Serious Adverse event
Frafald, bivirkninger
Sponsorship source: The sponsor provided funds anddrugs, labeled the randomized drug, and had the only copy ofthe randomization code. The study was reviewed and approvedby the Food and Drug Administration and was approved by theInstitutional Review Board for the Protection of HumanSubjects at Vanderbilt University and by the other 11 individ-ual study sites
Country: USA
Setting: not reported
Comments:
Authors name: T. Pincus,1G. G. Koch,2T. Sokka, et al.
Institution: Division of Rheumatology and Immunology, Vanderbilt Univer-sity School of Medicine, USA
Email: not reported
Address: . Pincus,MD, Division of Rheumatology and Immunology, Vanderbilt Univer-sity School of Medicine, 203 Oxford House, Box 5, Nashville, TN37232-450; USA
Fagkonsulent Nkr40 on 06/02/2016 05:41
Outcomes
NB - i serious adverse events er alle der har fået Acetaminophen (dvs. event i gr. 1 og 2 kombineret)I frafald, er det kun de første 6 uger svarende til 1. periode, der af rapporteret
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Paracetamol (regular group)
paracetamol (as-needed)
Placebo
Included criteria: a new episode of acute low-backpain (defi ned as pain between the 12th rib and buttockcrease that was shorter than 6 weeks’ duration andpreceded by 1 month of no pain) with or without leg pain,and at least moderate-intensity pain (measured by anadaptation of item 7 of the Short Form [36] HealthSurvey
Excluded criteria: Exclusion criteria were suspected serious spinalpathology (eg, spinal cancer, infection, fracture); currentuse of full, regular recommended doses of an analgesic;spinal surgery in the preceding 6 months; contraindicationto paracetamol; use of psychotropic drugs for a disorderjudged to prevent reliable recording of study information;or pregnant or planning pregnancy.
Pretreatment: similar across groups
Intervention Characteristics
Paracetamol (regular group)
paracetamol (as-needed)
Placebo
pain
Disability
Serious Adverse event
Frafald, generelt
Sponsorship source: AJM has received funding for a postgraduate research scholarshipfrom GlaxoSmithKline. CGM has received funding to review teachingmaterials prepared by GlaxoSmithKline. The other authors declare nocompeting interests.
Country: Australia
Setting: primary care
Comments:
Authors name: Christopher M Williams, Christopher G Maher, Jane Latimer, Andrew J McLachlan, Mark J Hancock, Richard O Day, Chung-Wei Christine Lin
Institution: The George Institute for Global Health, Sydney Medical School, University of Sydney, Camperdown, NSW, Australia
Email: cwilliams@georgeinstitute. org.au
Address: Hunter Medical ResearchInstitute, Longworth Avenue,Wallsend, NSW 2287, Australia
language
Wrong study design
Wrong comparator
Unable to obtain
Wrong outcomes
Wrong outcomes
Wrong route of administration
Wrong outcomes
Wrong study design
Wrong intervention
Wrong route of administration
Wrong study design
Wrong outcomes
Wrong outcomes
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Detection bias due to knowledge of the allocated interventions by outcome assessors
Attrition bias due to amount, nature or handling of incomplete outcome data
Reporting bias due to selective outcome reporting
Bias due to problems not covered elsewhere in the table
Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.
Judgement Comment: RoB fra Machado (2015) SR
Describe the method used to conceal the allocation sequence in sufficient detail to determine wether intervention allocations could have been foreseen in advance of, during, enrolement.
Quote: "patients was concealed from personnel at the study sites and data center."
Describe all measures used, if any to blind study participants and personnel from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
Quote: "double-blind,"
Judgement Comment: No specification of how double-blinding was achieved
Describe all measures used, if any to blind outcome assessors from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
Judgement Comment: not reported
Describe the completeness of outcome data for each main outcome, including attrition and exlusions from the analysis. State whether attrition and exclusions were reported, the numbers in each intervention group (compared with total randomized participants), reasons for attrition/exclusions where reported, and any re-inclusions in analyses performed by the review authors.
Judgement Comment: Correction - follow rates are provided in figure - however, high droop out rate
State how the possibility of selective outcome reporting was examined by the review authors and what was found.
Quote: "The study was reviewed and approved by the Food and Drug Administration and was approved by the Institutional Review Board for the Protection of Human Subjects at Vanderbilt University and by the other 11 individ- ual study sites."
Judgement Comment: no protocol available, but unlikely
State any important concerns about bias not addressed in the other domains in the tool. If particular questions/entries were re-specified in the review's protocol, responses should be provided for each question/entry.
Judgement Comment: General lack of reporting of methodology